Regulatory Compliance Officer

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time
Job Overview:
Mundipharma is seeking a highly skilled Regulatory Compliance Officer to join our team in Cambridge. As a key member of our Quality Assurance team, you will be responsible for ensuring the quality and compliance of our pharmaceutical products. Your primary responsibility will be to provide front-line QA support in the manufacturing operations, conducting walkabouts to ensure continuous compliance with GMP and company requirements.

About the Role:
We are looking for a highly motivated and experienced individual with a strong background in Quality Assurance and regulatory compliance. The ideal candidate will have a scientific degree in Pharmacy, Chemistry, Biology, Engineering or similar, or aligned working experience. You will also need practical experience in QA roles within the Pharmaceutical and/or Medical Devices Industry. Additionally, you should have knowledge and application of GMP and Pharmaceutical regulatory requirements, including solid knowledge of Eudralex Vol. 4 Chapters and Annexes, Orange Guide and key EU Directives.

Key Responsibilities:
- Provide front-line QA support in the manufacturing operations, conducting walkabouts to ensure continuous compliance with GMP and company requirements.
- Advise in the event of deviations, including containment actions and product disposition, liaising with senior members of the QA team and/or QA Manager and Qualified Person.
- Lead/facilitate Quality investigations for the identification of root causes and continuous improvements as a result of Deviations and/or Customer Complaints in conjunction with the relevant functional areas.

Salary and Benefits:
A competitive salary of £45,000 per annum, depending on experience, plus a flexible benefits package and opportunities for career growth and development.

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